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    DRUG:

    FPI-2265

    i
    Other names: FPI-2265, Ac225-PSMA I&T, 225Actinium-PSMA-I&T, FPI2265, FPI 2265, AZD2265, AZD-2265
    Associations

    News

    Trials
    Company:
    AstraZeneca
    Drug class:
    Alpha radiation emitter, PSMA inhibitor
    Related drugs:
    Associations

    News

    Trials
    1m
    PROSPECTOR: Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1/2, N=152, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FOLH1 positive
    |
    docetaxel • AZD9574 • FPI-2265
    2ms
    AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) (clinicaltrials.gov)
    P3, N=670, Recruiting, AstraZeneca
    New P3 trial
    |
    FOLH1 positive
    |
    enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • cabazitaxel • apalutamide • Xofigo (radium Ra-223 dichloride) • AiRuiEn (rezvilutamide) • FPI-2265 • prednisolone
    3ms
    PROSPECTOR: Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1/2, N=152, Not yet recruiting, AstraZeneca
    New P1/2 trial
    |
    FOLH1 positive
    |
    docetaxel • AZD9574 • FPI-2265
    3ms
    FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P2, N=85, Active, not recruiting, Fusion Pharmaceuticals Inc. | Trial completion date: Aug 2030 --> May 2027 | Trial primary completion date: Jan 2030 --> May 2027
    Trial completion date • Trial primary completion date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation • FOLH1 positive
    |
    Lynparza (olaparib) • FPI-2265
    4ms
    AlphaBreak: FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P2, N=110, Active, not recruiting, Fusion Pharmaceuticals Inc. | Trial primary completion date: Jul 2026 --> Dec 2026 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial primary completion date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation • FOLH1 positive
    |
    FPI-2265
    10ms
    AlphaBreak: FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P2, N=100, Recruiting, Fusion Pharmaceuticals Inc. | Phase classification: P2/3 --> P2
    Phase classification
    |
    FPI-2265
    10ms
    Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST). (clinicaltrials.gov)
    P2, N=115, Active, not recruiting, Fusion Pharmaceuticals Inc. | Trial completion date: Jul 2025 --> Jul 2026
    Trial completion date
    |
    MSI (Microsatellite instability) • BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    FPI-2265
    12ms
    FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P2, N=85, Active, not recruiting, Fusion Pharmaceuticals Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Lynparza (olaparib) • FPI-2265
    over1year
    AlphaBreak: FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P2/3, N=100, Recruiting, Fusion Pharmaceuticals Inc. | N=60 --> 100
    Enrollment change
    |
    FPI-2265
    over1year
    FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P2, N=85, Recruiting, Fusion Pharmaceuticals Inc.
    New P2 trial
    |
    Lynparza (olaparib) • FPI-2265
    over1year
    Targeted Alpha Therapy with 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST). (clinicaltrials.gov)
    P2, N=115, Active, not recruiting, Fusion Pharmaceuticals Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jul 2025 | Trial primary completion date: Dec 2024 --> Apr 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    MSI (Microsatellite instability) • BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    FPI-2265
    over2years
    AlphaBreak: FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P2/3, N=60, Recruiting, Fusion Pharmaceuticals Inc.
    New P2/3 trial • Metastases
    |
    FPI-2265